Neurofax

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name: NEUROFAX FDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: NEUROFAX EEG DIGITAL, TOWER FDA UDI
Model / Reference: EEG-9200A FDA UDI
Description: NEUROFAX EEG DIGITAL, TOWER FDA UDI

Identifiers

Catalog Number: EEG-9200A FDA UDI
Primary DI / UDI-DI: 00841983103209 FDA UDI
FDA Product Code: OLV FDA UDI
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electroencephalograph

Neurofax by Nihon Kohden America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nihon Kohden America, Inc.

Sources (1)

FDA UDI 4843ddae-7cd1-4558-81cc-e59b60db6cfa 35 fields · synced May 30, 2026